norspan transdermal patches study in osteoarthritis patients

Conditions: Osteoarthritis Disorders

Summary: this is a single center, open label, randomized, parallel group single dose pharmacokinetic (pk) study.

after up to 7-day screening period, eligible patients will be randomized to 1 of 3 treatment groups, and begin treatment with btds 5mg, 10mg,20mg for 7 days.venous blood will be collected at 0, 6, 12, 24, 36, 48, 60, 72, 96,120, 144,168,169,170,171,172,174,180,192,216, 240 h postdose respectively.plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: auc0-t, auc0-inf, cmax, tmax, t½.

Eligibility criteria:
inclusion criteria: * patients volunteering for participation in the study. * male and female patients with diagnosis of osteoarthritis, age from 20 to 60 years. * body weight ≥ 50kg , and bmi range ≧ 18.5, ﹤ 30. * having the results within the following ranges and having been judged as eligible for the study participation by the investigator:systolic blood pressure (supine), 90-140 mm hg,diastolic blood pressure (supine), 60-90 mm hg, armpit body temperature, 35.0-37.5 degree celsius. * agreed not to use any medication (except vitamins or mineral supplements) during the course of the study. * have not smoked or chewed tobacco for at least 45 days prior to dosing with study drugs, and agree not to use tobacco products during the study. * females of childbearing potential must have a negative serum pregnancy test during screening visit and at check-in. exclusion criteria: * subjects who have been taking opioid analgesic formulations excess 7 days within 3 months of visit 1. * subjects who have been taking cyp3a4 inhibitor or inducer within the last 1 month prior to the screening visit. * subjects who have been taking any medication including otc (except vitamin and/or mineral supplements) within 7 days prior to the first dose of the trial product. * patients who have a current chronic disease(s), or who have a past history and high possibilities to relapse, in addition to their musculo-skeletal pain, requiring frequent analgesic therapy. * subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis. * subject who have a past history of malignant neoplasm. * subjects with clinically unstable, active or symptomatic heart disease. * subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on. * subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs. * history of frequent nausea or emesis regardless of etiology. * subjects who have a current or past history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the screening period. * subjects scheduled for therapies within the study period which might effect study assessment. * subjects with values \> 2 times the upper limit of normal for ast or alt or total bilirubin during the screening period or who have severe impaired liver function. * subjects with serum creatinine \> 2 mg/dl during the screening period or who have severe impaired renal function. * subjects with serum potassium \< 3.5 meq/l during the screening period. * subjects with positive result of anti-human immunodeficiency virus antibodies, hepatitis b surface antigen, hepatitis c virus antibody or qualitative syphilis tests. * donated 400 ml or more of blood or blood products within 3 months prior to the start of the study, or donated 200 ml or more of blood or blood products within 1 month prior to the start of the study. * subjects who have a history of supersensitivity to study drug. * subjects who participated in a clinical research study within 1 month of study entry. * subjects who participated previously in a btds study.

Keywords: osteoarthritis disorders